Naltrexone in the Treatment of Trichotillomania

Trichotillomania Clinical Trial

Official title:

A Double-blind, Placebo-controlled Study of Naltrexone in Trichotillomania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00775229
• Other study ID #: 0806M36061
• Status: Completed
• Phase: Phase 2
• Start date: August 2008
• Est. completion date: December 2012

Study information

• Verified date: February 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania

Description:

The goal of the proposed study is to evaluate the efficacy of Naltrexone in trichotillomania. Forty subjects with DSM-IV trichotillomania will receive 8 weeks of double-blind Naltrexone or placebo. The hypothesis to be tested is that Naltrexone will be effective and well tolerated in patients with trichotillomania compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. men and women age 18-75;

2. current DSM-IV trichotillomania;

3. hair-pulling primarily due to urges/cravings; and 4) pulling is reported as pleasurable the majority of time.

Exclusion Criteria:

1. unstable medical illness or clinically significant abnormalities on pre-study laboratory tests or physical examination;

2. history of seizures;

3. myocardial infarction within 6 months;

4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential;

5. clinically significant suicidality;

6. current or recent (past 3 months) DSM-IV substance abuse or dependence;

7. illegal substance within 2 weeks of study initiation;

8. initiation of psychotherapy or behavior therapy from a mental health professional for the treatment of trichotillomania within 3 months prior to study baseline;

9. initiation of a psychotropic medication within 2 months prior to study inclusion;

10. previous treatment with naltrexone; and

11. treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline;

12. lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;

13. current use of opiates.

Related Conditions & MeSH terms

• Trichotillomania

Intervention

Drug:
• Naltrexone
pill, by mouth, 50mg-150mg/day for the duration of the study
• Placebo
pill, by mouth, daily

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	National Institute of Mental Health Trichotillomania Symptom Severity Scale	Ranges from 0-20 with 20 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.	This is the final score, measured at week 8 (final visit).
Secondary	Massachusetts General Hospital Hairpulling Scale	Ranges from 0-28 with 28 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.	This is the final score, measured at week 8 (final visit).
Secondary	Liver Function Tests	Participants were administered a general test of liver functioning to asses safety over the course of the study. Data represent the percentage of participates with Liver Function Test values falling outside of the range considered safe/typical for liver functioning at any of the assessed time points. It was performed at baseline and at each visit where dosage of the medication is >50mg/day (week 2-week 8).	Week 8 (last visit)